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S2k guideline for the treatment of hidradenitis suppurativa / acne inversa - Short version.
J Dtsch Dermatol Ges
June 2024
Hidradenitis Suppurativa Foundation e.V., Dessau, Germany.
Article Synopsis
- The S2k guideline for hidradenitis suppurativa/acne inversa (HS/AI) serves as a decision aid for selecting effective treatments for this chronic skin condition, which is characterized by painful lesions in areas rich in apocrine glands.
- The condition shows a prevalence of 0.3% in Germany, often diagnosed with a significant delay of about 10 years, and can severely impact a patient's quality of life due to the painful and recurrent nature of the disease.
- Treatment options include various medications like oral tetracyclines and biologics such as adalimumab, with a focus on assessing disease severity using tools like the International Hidradenitis Supp
Effectiveness of Immunization Products Against Medically Attended Respiratory Syncytial Virus Infection: Generic Protocol for a Test-Negative Case-Control Study.
J Infect Dis
March 2024
Centre for Infectious Disease Control, National Institute for Public Health and Environment, Bilthoven, the Netherlands.
Article Synopsis
- Monitoring the real-life effectiveness of respiratory syncytial virus (RSV) prevention methods, like monoclonal antibodies and vaccines, is crucial for public health.
- The study utilizes a generic protocol for a test-negative design, which can be adapted to various settings to assess effectiveness among children, older adults, and pregnant women.
- Endpoints include severe acute respiratory infection (SARI) and acute respiratory infection (ARI) related to RSV, applicable in both hospital settings for severe cases and general practitioner clinics for ARI patients.
Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk.
N Engl J Med
November 2022
From the Center for Cardiovascular Disease Prevention, Division of Preventive Medicine (A.D.P., R.J.G., J.G.M., E.S.Z., B.M.E., N.P.P., J.E.B., P.M.R) and the Division of Cardiovascular Medicine (B.M.E.,P.L., P.M.R.), Brigham and Women's Hospital, the Division of Cardiovascular Medicine, Veteran Affairs Boston Health Care System (A.D.P., J.J.), and Kowa Pharma Development (R.O.) - all in Boston; University of Lille, Lille (J.-C.F.) and the Department of Neurology and Stroke Center, Paris Cité University, Paris (P.A.) - both in France; Kowa Research Institute, Morrisville, NC (S.E.C.); the Division of Lipidology, Department of Medicine, University of Cape Town, Cape Town, South Africa (D.J.B.); Utah Lipid Center, Salt Lake City (E.A.B.); the University of Colorado School of Medicine, Aurora (R.H.E.); the University of Tennessee Health Science Center, Memphis (M.B.E.); the Division of Endocrinology, Universitário Hospital João de Barros Barreto, Belém (J.S.F.), and the Heart Institute (InCor), University of São Paulo Medical School Hospital, and Hospital Israelita Albert Einstein (R.D.S.), São Paulo - all in Brazil; Columbia University Vagelos College of Physicians and Surgeons, New York (H.N.G.); Queen Giovanna University Hospital, Sofia, Bulgaria (A.G.); Jichi Medical University, Shimotsuke (S.I.), the Research Center for Advanced Science and Technology, University of Tokyo, Tokyo (T.K.), and Chiba University Graduate School of Medicine, Chiba (K.Y.) - all in Japan; Deutsches Herzzentrum München, Technische Universität München and German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich (W.K.), Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm (W.K.), and Rheinisch-Westfälische Technische Hochschule Aachen, University Hospital Aachen, Aachen (N.M.) - all in Germany; McMaster University and Population Health Research Institute, Hamilton, ON (P.A.) and the Division of Endocrinology and Metabolism, St. Michael's Hospital, University of Toronto, Toronto (L.A.L.) - both in Canada; Docencia, Asistencia Médica e Investigación Clínica Medical Institute-Rusculleda Foundation for Research, Córdoba, Argentina (A.J.L.); Shupyk National Healthcare University of Ukraine, Kyiv (B.M.); Copenhagen University Hospital-Herlev Gentofte, University of Copenhagen, Copenhagen (B.G.N.); the Department of Medical Clinical Pharmacology, University of Debrecen, Debrecen, Hungary (D.P.); the Department of Primary Care and Public Health, Imperial College London, London (K.K.R.), and the Department of Endocrinology, Diabetes, and Metabolism, Manchester University Hospital NHS Foundation Trust, Manchester (H.S.) - both in the United Kingdom; the Russian Academy of Postgraduate Medical Education, Moscow (A.S.); and the Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland (M.T.).
Background: High triglyceride levels are associated with increased cardiovascular risk, but whether reductions in these levels would lower the incidence of cardiovascular events is uncertain. Pemafibrate, a selective peroxisome proliferator-activated receptor α modulator, reduces triglyceride levels and improves other lipid levels.
Methods: In a multinational, double-blind, randomized, controlled trial, we assigned patients with type 2 diabetes, mild-to-moderate hypertriglyceridemia (triglyceride level, 200 to 499 mg per deciliter), and high-density lipoprotein (HDL) cholesterol levels of 40 mg per deciliter or lower to receive pemafibrate (0.
Switching from Adalimumab Originator to Biosimilar in Patients with Hidradenitis Suppurativa Results in Losses of Response-Data from the German HS Registry HSBest.
Life (Basel)
September 2022
Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), 20251 Hamburg, Germany.
Article Synopsis
- * A study analyzed 94 patients who switched from ADAO to ABP 501, and found that 33.3% experienced adverse events (AEs) or loss of response (LoR) within 12 to 14 weeks after the switch.
- * The findings suggest that switching from ADAO to ABP 501 significantly impacts treatment effectiveness, indicating that such switches should be carefully considered, especially for patients maintaining remission.
Integrated Process Model Applications Linking Bioprocess Development to Quality by Design Milestones.
Bioengineering (Basel)
October 2021
Koerber Pharma Software PAS-X Savvy, Mariahilfer Straße 88A/1/9, 1070 Vienna, Austria.
Maximizing the value of each available data point in bioprocess development is essential in order to reduce the time-to-market, lower the number of expensive wet-lab experiments, and maximize process understanding. Advanced in silico methods are increasingly being investigated to accomplish these goals. Within this contribution, we propose a novel integrated process model procedure to maximize the use of development data to optimize the Stage 1 process validation work flow.
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